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Parkinson DiseaseNCT06536348

PARKINSON BRASIL - Database on Motor and Non-Motor Aspects of Parkinson's Disease in Brazil

An observational study of Parkinson Disease, run by Federal University of Uberlandia at 5 sites in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an observational, cross-sectional study with a control group, with the general objective of developing and evaluating a national database, unprecedented in Brazil, containing clinical, epidemiological, motor, and non-motor aspects of Parkinson's disease (PD). Read more about this study

Who is it for?
Ages 18 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Parkinson Disease
How many people
958 participants
Where
5 sitesBrazil
Study dates
1 Jan 2025to 1 Oct 2034
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: * Experimental group: Individuals diagnosed with Parkinson's disease * Control group: Individuals not having Parkinson's disease (PD) or other neurological disease that resembles PD;

Who may be able to join

  • Experimental group: (i) present a neurological diagnosis of Parkinson's disease; (ii) be classified between stages I to IV of the Hoehn \& Yahr Scale; (iii) have central visual acuity equal to or greater than 20/40 (equivalent to 0.50) in each eye or equal to or greater than 20/30 (equivalent to 0.66) in one eye according to the Snellen scale.
  • Control group: (i) not having a neurological diagnosis of Parkinson's disease or other neurological disease that resembles PD; (ii) have central visual acuity equal to or greater than 20/40 (equivalent to 0.50) in each eye or equal to or greater than 20/30 (equivalent to 0.66) in one eye according to the Snellen scale.

Who cannot join

  • For both groups, individuals who have other neurological or musculoskeletal diseases that interfere with the execution of the tests will be excluded.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Adriano Andrade, PhD contact

+55 34 3239-4761

adriano@ufu.br

Adriano Andrade, PhD contact

+ 34 3239-4761

adriano@ufu.br

5 sites in 1 country

Brazil5 sites, 5 recruiting

  • Laboratório de Análise de Movimento e Processamento de Sinais

    Brasília, Federal District, 72220-275

    Clarissa Cardoso dos Santos Couto Paz, PhD, clarissacardoso@unb.br

    Not yet recruiting

  • Centro Universitário Araguaia (UniAraguaia)

    Goiânia, Goiás, 74.223-060

    Tatiana Carilly Oliveira Andrade, PhD, tatiana@uniaraguaia.edu.br

    Recruiting

  • Associação Parkinson Goiás

    Goiânia, Goiás, 74265-320

    Adriano Andrade, PhD, adriano@ufu.br

    Not yet recruiting

  • Ambulatório de Doença de Parkinson e Distúrbios do Movimento do Hospital de Clínicas de Uberlândia

    Uberlândia, Minas Gerais, 38405-318

    Adriano Andrade, PhD, adriano@ufu.br

    Recruiting

  • Núcleo de Inovação e Avaliação Tecnológica em Saúde / Centre for Innovation and Technology Assessment in Health

    Uberlândia, Minas Gerais, 38408-100

    Adriano Andrade, PhD, adriano@ufu.br

    Recruiting

Other trials in Brazil

About this study

This is an observational, cross-sectional study with a control group, with the general objective of developing and evaluating a national database, unprecedented in Brazil, containing clinical, epidemiological, motor, and non-motor aspects of Parkinson's disease (PD). The database will be open and accessible to national and international researchers in order to contribute to the advancement of research related to PD. The aim is to collect data, in a paired way, from a control group and an experimental group. Data collection will include the application of questionnaires, the execution of motor activities, and clinical scales. Information that can identify the participants will be removed from the database for later storage in a repository. Quantitative, qualitative, and descriptive variables from the database will be estimated in order to characterise and contrast the groups studied. The results of this study will contribute to a better characterization of the staging of PD as a function of the epidemiological, motor, and non-motor aspects evaluated, as well as to the development of technologies and methods that can be applied in clinical practice.

Keywords
Parkinson's disease, motor assessment, non-motor assessment, database, computer vision, inertial sensors
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06536348
Study groupRoleWhat they receive
Experimental groupGroup of subjects with Parkinson's disease
Control groupNeurological healthy subjects

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sex

    Sex: male, female

    Measured: 10 years

  2. Age

    Age in years

    Measured: 10 years

  3. Length of schooling

    Length of schooling in years

    Measured: 10 years

  4. Weight

    Weight in kg

    Measured: 10 years

  5. Height

    Height in cm

    Measured: 10 years

  6. Blood type

    Blood type: A+, A-, B+, B-, O+, O-, AB+, AB-

    Measured: 10 years

  7. Economic Rating Score

    Economic rating as given by the Brazilian Economic Classification Criteria (Brazilian Criteria) - https://www.abep.org/criterioBr/01_cceb_2022_eng.pdf

    Measured: 10 years

  8. Primary ICD

    Primary disorder classification according to the International Statistical Classification of Diseases and Related Health Problems (ICD) https://www.who.int/standards/classifications/classification-of-diseases

    Measured: 10 years

  9. Secondary ICDs

    Secondary disorder according to the International Statistical Classification of Diseases and Related Health Problems (ICD) https://www.who.int/standards/classifications/classification-of-diseases

    Measured: 10 years

  10. Medications in use

    name and daily dose of medications

    Measured: 10 years

  11. Family history related to the primary ICD

    Is there family history related to the primary ICD? (yes, no)

    Measured: 10 years

  12. Date of symptom onset related to the primary ICD

    date

    Measured: 10 years

  13. Date of diagnosis related to the primary ICD

    date

    Measured: 10 years

  14. Current city of residence

    City of residence in Brazil

    Measured: 10 years

  15. Current state of residence

    State of residence in Brazil

    Measured: 10 years

  16. Civil status

    married, single, divorced, and widowed

    Measured: 10 years

  17. Housing classification

    Housing classification by type of housing ownership rights: State-owned housing, Municipality-owned housing, Natural person's owned housing, Legal person's owned housing, Private renting, Other

    Measured: 10 years

  18. Household size

    The number of adults and children living in a home

    Measured: 10 years

  19. Laterality

    Laterality refers to the preference for using one side of the body over the other and is most commonly associated with hand dominance, such as being right-handed or left-handed, e.g., Right-handedness, Left-handedness, Ambidexterity, Mixed-handedness (Cross-dominance).

    Measured: 10 years

  20. Use of technology

    Verification if the participant has had contact with one of the following devices: mobile, personal computer, mouse, webcam, keyboard, microphone, earphone.

    Measured: 10 years

  21. Occupation

    Profession according to the Brazilian Classification of Occupation (https://www.mtecbo.gov.br/cbosite/pages/home.jsf)

    Measured: 10 years

  22. Monthly wage

    Monthly wage in Brazilian Reais

    Measured: 10 years

  23. Head movement amplitude

    Head movement amplitude in degrees

    Measured: 10 years

  24. Head movement speed

    Head movement speed in degrees per second

    Measured: 10 years

  25. Facial expression

    Facial expression evaluation according to the Facial Action Coding System (FACS)

    Measured: 10 years

  26. Saccadic eye movement

    Speed and regularity of eye movement (degrees per second and latency in ms)

    Measured: 10 years

  27. Smooth pursuit eye movement

    Smooth pursuit are quantified by the gain (how well the eyes follow the target in speed) and phase (distance to the target during pursuit)

    Measured: 10 years

  28. Handwriting movement analysis

    Handwriting speed (seconds) and quality

    Measured: 10 years

  29. MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Clinical scale for measuring signs and symptoms of Parkinson's disease (https://www.movementdisorders.org/MDS/MDS-Rating-Scales/MDS-Unified-Parkinsons-Disease-Rating-Scale-MDS-UPDRS.htm?gad_source=1\&gclid=CjwKCAjwnqK1BhBvEiwAi7o0X6DuHrFh3qftNQ1N9AGWMkFo4BpG6b3hAFWnoh2Dwu86DPY53ZXpKRoCBRYQAvD_BwE)

    Each item of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale will be evaluated as 0: Normal; 1: Slight; 2: Mild; 3: Moderate; 4: Severe.

    The minimum value of the scale is 0, whereas the maximum value is 4. Higher scores mean a worse outcome.

    Measured: 10 years

  30. Depression

    Depression measured according to the Geriatric Depression Scale (GDS) https://geriatrictoolkit.missouri.edu/cog/GDS_SHORT_FORM.PDF

    The Geriatric Depression Scale has 15 items. The minimum total score is zero, and the maximum is 15. Higher scores mean a worse outcome.

    Measured: 10 years

  31. Visual Acuity

    Visual Acuity measured according to the Snellen test (https://www.ncbi.nlm.nih.gov/books/NBK558961/)

    Measured: 10 years

  32. Cognition

    Cognition measured according to the Montreal Cognitive Assessment (MOCA) scale

    The Montreal Cognitive Assessment (MoCA) is a 30-point test. The minimum total score is zero, and the maximum is 30. Higher scores mean a better outcome.

    Measured: 10 years

  33. Dysarthria

    Dysarthria measured according to the protocol for the evaluation of central dysartries in patients with Parkinson's Disease (https://doi.org/10.1590/S1516-18462011005000030)

    Measured: 10 years

  34. Hand movement

    Hand movement in degrees per second

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Oct 2034 (estimated)
  4. Study completion1 Oct 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
958 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06536348
Sponsor's protocol ID
81274724.0.0000.5152
Other IDs
13585
Status last verified
May 2026
First submitted
28 Jul 2024
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The data will be anonymised, stored in a safe and international plataform (Zenodo - https://github.com/NIATS-UFU). Only information that can be used to identify the subjects will be shared.

Publications

  • Poewe W, Seppi K, Tanner CM, Halliday GM, Brundin P, Volkmann J, Schrag AE, Lang AE. Parkinson disease. Nat Rev Dis Primers. 2017 Mar 23;3:17013. doi: 10.1038/nrdp.2017.13.

    PubMed 28332488

  • World Health Organization, Parkinson disease, 2023.

  • Barbosa MT, Caramelli P, Maia DP, Cunningham MC, Guerra HL, Lima-Costa MF, Cardoso F. Parkinsonism and Parkinson's disease in the elderly: a community-based survey in Brazil (the Bambui study). Mov Disord. 2006 Jun;21(6):800-8. doi: 10.1002/mds.20806.

    PubMed 16482566

  • Vale TC, Barbosa MT, Resende EPF, Maia DP, Cunningham MCQ, Guimaraes HC, Machado JCB, Teixeira AL, Cardoso F, Caramelli P. Parkinsonism in a population-based study of individuals aged 75+ years: The Pieta study. Parkinsonism Relat Disord. 2018 Nov;56:76-81. doi: 10.1016/j.parkreldis.2018.06.030. Epub 2018 Jun 19.

    PubMed 29934195

  • Simon DK, Tanner CM, Brundin P. Parkinson Disease Epidemiology, Pathology, Genetics, and Pathophysiology. Clin Geriatr Med. 2020 Feb;36(1):1-12. doi: 10.1016/j.cger.2019.08.002. Epub 2019 Aug 24.

    PubMed 31733690

  • Obeso JA, Rodriguez-Oroz MC, Rodriguez M, Lanciego JL, Artieda J, Gonzalo N, Olanow CW. Pathophysiology of the basal ganglia in Parkinson's disease. Trends Neurosci. 2000 Oct;23(10 Suppl):S8-19. doi: 10.1016/s1471-1931(00)00028-8.

    PubMed 11052215

  • Tysnes OB, Storstein A. Epidemiology of Parkinson's disease. J Neural Transm (Vienna). 2017 Aug;124(8):901-905. doi: 10.1007/s00702-017-1686-y. Epub 2017 Feb 1.

    PubMed 28150045

  • Dickson JM, Grunewald RA. Somatic symptom progression in idiopathic Parkinson's disease. Parkinsonism Relat Disord. 2004 Dec;10(8):487-92. doi: 10.1016/j.parkreldis.2004.05.005.

    PubMed 15542009

  • Cabral AM, Lora-Millan JS, Pereira AA, Rocon E, Andrade AO. On the Effect of Vibrotactile Stimulation in Essential Tremor. Healthcare (Basel). 2024 Feb 9;12(4):448. doi: 10.3390/healthcare12040448.

    PubMed 38391822

  • Cardoso Mendes L, Abreu Rosa de Sa A, Alves Marques I, Morere Y, de Oliveira Andrade A. RehaBEElitation: the architecture and organization of a serious game to evaluate motor signs in Parkinson's disease. PeerJ Comput Sci. 2023 Mar 15;9:e1267. doi: 10.7717/peerj-cs.1267. eCollection 2023.

    PubMed 37346638

  • S. Costa, I. A. Marques, A. Bevilaqua, A. Rabelo, L. Luiz, A. Cabral, N. Faustino, M. Okereke, M. Fraga Vieira e A. de Oliveira Andrade, "Biomechanical Evaluation of an Exoskeleton for Rehabilitation of Individuals with Parkinson's Disease," IRBM, vol. 44, p. 100741, February 2023

  • L. C. Mendes, A. M. Cabral, C. M. Alves, Y. Morère e A. de Oliveira Andrade, "Objective assessment of tremor in Parkinson's disease using the RehaBEElitation serious game," em 2023 IEEE International Conference on Metrology for eXtended Reality, Artificial Intelligence and Neural Engineering (MetroXRAINE), 2023

  • Mendes LC, Marques IA, Alves CM, Vieira MF, Junior EAL, Pereira AA, Naves ELM, Oliveira FHM, Bourhis G, Pino P, Morere Y, Andrade AO. Multidimensional Assessment of Individuals with Parkinson's Disease: Development and Structure Validation of a Self-Assessment Questionnaire. Healthcare (Basel). 2022 Sep 21;10(10):1823. doi: 10.3390/healthcare10101823.

    PubMed 36292272

  • Nobrega LR, Rocon E, Pereira AA, Andrade AO. A Novel Physical Mobility Task to Assess Freezers in Parkinson's Disease. Healthcare (Basel). 2023 Jan 31;11(3):409. doi: 10.3390/healthcare11030409.

    PubMed 36766984

  • L. C. Mendes, A. Moura Cabral, C. M. Alves, Y. Morere, I. A. Marques e A. de Oliveira Andrade, "Objective Evaluation of Bradykinesia Using the RehaBEElitation Serious Game," em 2022 IEEE Workshop on Complexity in Engineering (COMPENG), 2022.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Federal University of Uberlandia at 5 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adriano Andrade, PhD (+55 34 3239-4761, adriano@ufu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sex (time frame: 10 years). The study lists 34 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06536348, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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